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| ID | Type | Description | Link |
|---|---|---|---|
| ClinicalTrials.gov Identifier: | Registry Identifier | ClinicalTrials.gov |
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During weaning the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time on ventilators is spent weaning. Studies support the use of screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to identify weaning candidates. The investigators work demonstrates that once daily screening is the current standard of care. The conduct of daily ward rounds and once daily screening in ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more often, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may be influenced by the presence of comorbidities, frailty, malnutrition and treatment limitations.
The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years) critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in 8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess whether protocols can be adhered to similarly between elderly (65 to 80 years) and very elderly (>80 years) trial participants. Moreover, they will also address generalizability issues in the conduct of mechanical ventilation research by evaluating potential biases associated with exclusion criteria and consent between elderly and very elderly patients and obtain preliminary estimates of differences in important clinical outcomes between elderly and very elderly participants.
In the context of a multicentre, pilot trial in 100 elderly (>/= 65 years) critically ill adults comparing two strategies to identify weaning candidates ('once daily' vs. 'at least twice daily' screening) in 8 ICUs across Canada, we propose to assess feasibility metrics that reflect our ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT.
Primary Research Question (i) Can we recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing alternative screening strategies?
Secondary Research Questions (ii) Can clinicians adhere to the assigned screening protocols in both study arms?
Tertiary Research Questions
(ii) What are the proportions of enrolled elderly and very elderly trial participants? (iii) Are the proportions of consents obtained and declined for trial participation similar between eligible elderly and very elderly trial participants? (iv) What are the rates and reasons for trial exclusion based between eligible elderly and very elderly patients? (v) What effect, in preliminary estimates, do the alternative screening strategies have on clinically important outcomes[e.g., time to first Spontaneous Breathing Trial (SBT) and first successful SBT, time to first extubation and successful extubation, total duration of mechanical ventilation, intensive care unit (ICU) and hospital length of stay, ICU and hospital mortality, use of noninvasive ventilation (NIV) following extubation, complications (self-extubation, tracheostomy, reintubation, proportion requiring prolonged mechanical ventilation) and adverse events] between elderly and very elderly trial participants.
Quaternary Research Questions
(i) Can we assess and quantify current practices related to sedation, analgesia an delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments of weaning readiness with the goal of quantifying factors that may lead to performance bias in the future, planned, large scale weaning trial.
(ii) Can we identify barriers (clinician and institutional) to recruitment into this study? (iii) Can we classify trial participants as requiring (i) simple, (ii) difficult or (iii) prolonged weaning using the 'Task Force on Weaning' definitions.
Hypotheses
We hypothesize that we will achieve our feasibility metrics, specifically, that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily screening | Active Comparator | In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. |
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| At least twice daily screening | Experimental | In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hours daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team (RTs and physicians). Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once daily screening | Procedure | In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, continuous positive airway pressure (CPAP) less than or equal to 5 cm H2O or PS less than or equal to 8 cm H2O with PEEP less than or equal to 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for patients enrolled at their centre. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruit, on average, 2 elderly invasively ventilated, critically ill patients per ICU per month. | As a feasibility trial, the investigators propose to assess feasibility metrics that reflect their ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT including whether they can recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing the alternative screening strategies. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adhere to the assigned screening protocols in both study arms. | The investigators will assess whether clinicians can adhere to the assigned screening protocols in both study arms. They will consider compliance rates of at least 80% to be acceptable in both study arms and contamination in the once daily screening arm will be < 10%. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of enrolled elderly and very elderly trial participants | Comparison of the proportions of enrolled elderly and very elderly trial participants. | 12 months |
| Proportion of consents obtained and declined for trial participation |
Inclusion Criteria:
The investigators will include:
Exclusion Criteria:
The investigators will exclude patients who have already undergone extubation or an SBT, are unlikely to benefit (e.g. moribund, expected brain death), on automated weaning modes, participating in studies with a weaning protocol, and those who can not be optimized with regard to sedation and mobilization.
Specifically, we will exclude patients:
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| Name | Affiliation | Role |
|---|---|---|
| Karen E. A. Burns, MD, FRCPC | St. Michael's Hospital (Toronto, Canada) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | Canada | |||
| Hamilton General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30920411 | Derived | Burns KEA, Wong JTY, Dodek P, Cook DJ, Lamontagne F, Cohen A, Mehta S, Kho ME, Hebert PC, Aslanian P, Friedrich JO, Brochard L, Rizvi L, Hand L, Meade MO, Amaral AC, Seely AJ; Canadian Critical Care Trials Group. Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials. Crit Care Med. 2019 Jun;47(6):817-825. doi: 10.1097/CCM.0000000000003722. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2020 | |
| Reset | May 19, 2020 | |
| Release | May 17, 2022 | |
| Reset | Feb 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2020 | May 19, 2020 | |||
| May 17, 2022 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| At least twice daily screening | Procedure | In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be conducted in the same manner as in the once daily screening arm. The subsequent SBTs will be 30 -120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and with the use of different humidification strategies. Each centre will be asked to choose one technique for all patients enrolled at their centre. |
|
Compare the proportions of consents obtained and declined for trial participation similar between eligible elderly and very elderly trial participants.
| 12 months |
| Rates and reasons for trial exclusion | Description of the rates and reasons for trial exclusion based between eligible elderly and very elderly patients. | 12 months |
| Effect of the alternative screening strategies on clinically important outcomes (see below) between elderly and very elderly trial participants? | Compare, in preliminary estimates, the effect of the alternative screening strategies on clinically important outcomes [time to first SBT, time to first successful SBT, time to first extubation and successful extubation, total duration of mechanical ventilation, ICU and hospital length of stay, ICU and hospital mortality, use of noninvasive ventilation (NIV) after extubation and complications rates [reintubation, self-extubation, tracheostomy, prolonged mechanical ventilation > 7d and > 21 d] and adverse event rates between elderly and very elderly trial participants.](streamdown:incomplete-link) | 12 months + 2 months follow up |
| Hamilton |
| Ontario |
| Canada |
| St Joseph's Hospital | Hamilton | Ontario | Canada |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Hôpital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Universite Hopitalier de Sherbrooke | Sherbrooke | Quebec | Canada |
| Feb 16, 2023 |